NCT00938288

Brief Summary

The aim of this study is to determine the pharmacokinetics, safety and tolerability of KW-3357 in asymptomatic subjects with congenital antithrombin deficiency.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Apr 2009

Typical duration for phase_1

Geographic Reach
3 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 10, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 13, 2009

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

October 17, 2024

Status Verified

October 1, 2024

Enrollment Period

1.7 years

First QC Date

July 10, 2009

Last Update Submit

October 15, 2024

Conditions

Congenital Antithrombin Deficiency

Keywords

AntithrombinThrombosisPharmacokineticsHereditary Antithrombin DeficiencyCongenital Antithrombin Deficiency

Outcome Measures

Primary Outcomes (1)

  • To evaluate the pharmacokinetic profile of a single dose (50 IU/kg) of KW 3357 in subjects with congenital AT deficiency

    July 2011

Secondary Outcomes (1)

  • To determine the safety and tolerability of a single dose (50 IU/kg) of KW-3357 in subjects with congenital AT deficiency

    July 2011

Study Arms (1)

1

OTHER

Single group

Drug: KW-3357

Interventions

KW-3357DRUG

50IU/mL, IV single dose

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female subjects at least 18 years of age with congenital Antithrombin deficiency (AT activity ≤60% of normal) in a stable condition without evidence of acute thromboembolic events
  • Signed IEC-approved Informed Consent Form
  • Subjects must not have received an infusion of Antithrombin for at least 14 days before Screening
  • Patients of reproductive potential must agree to follow accepted birth control methods during the study

You may not qualify if:

  • Subjects who are classified as morbidly obese (defined by the presence of a body mass index \>40 kg/m2)
  • Subjects who have participated in a study with an investigational drug within 30 days of Screening or within 5.5 times the elimination half-life of the investigational drug before Screening, whichever period is greater
  • Subjects with any clinically relevant medical history or current condition or physical findings, ECG, or laboratory values which could interfere with the objectives of the study or the safety of the subject
  • Subjects using non-steroidal anti-inflammatories, fondaparinux sodium, dabigatran or rivaroxaban or who are expected to be treated with these drugs during the study
  • Subjects who have concomitant nephrotic syndrome
  • Female subjects who are pregnant or lactating
  • Subjects who are taking heparin, low molecular weight heparin and/or oral anticoagulants, with the exception of vitamin K antagonists (eg, warfarin)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Department of Haemotogy, Haemastasy, Oncology and Stem Cell Transplantation, Hannover Medical School

Hanover, 30625, Germany

Location

Center for Thrombosis and Haemostasis, Malmo University Hospital

Malmo, SE-205 02, Sweden

Location

Dept Obst Gyn/Section for Women and Child Health/Clinical Trial Unit, Karolinska University Hospital

Stockholm, SE-171 76, Sweden

Location

Treliske, Haematology Clinic, Royal Cornwall Hospital

Truro, Cornwall, TR1 3LJ, United Kingdom

Location

Bristol Haemophia Care Centre, Bristol Haemotology and Oncology Centre

Bristol, BS2 8ED, United Kingdom

Location

Department of Haemotology, Glasgow Royal Infirmary

Glasgow, G4 0SF, United Kingdom

Location

Kings College, Dept of Haematology, Lupus & Pathology Guy's and St Thomas Trust, St Thomas Hospital, Ctr for Haemostasis and Thrombosis (the Haemophia Reference Ctr)

London, SE1 7EH, United Kingdom

Location

University College London Hospital NHS Trust

London, WIT 4EU, United Kingdom

Location

MeSH Terms

Conditions

ThrombosisAntithrombin III Deficiency

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular DiseasesBlood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesBlood Protein DisordersThrombophiliaGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Beverley Hunt, FRCP, FRCPath MD

    St Thomas' Hospital, London, UK

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2009

First Posted

July 13, 2009

Study Start

April 1, 2009

Primary Completion

December 22, 2010

Study Completion

April 1, 2011

Last Updated

October 17, 2024

Record last verified: 2024-10

Locations

GB(5)DE(1)SE(2)